Study Details

Participation Requirements

Age

18 Years +

Sex

All

Healthy Volunteers

Medical Condition

Relapsed/Refractory Mantle Cell Lymphoma

Gender

N/A

Date

November 2015 - July 2019

Study Type

Interventional

Study Phase

Phase 2

Product

brexucabtagene autoleucel, Cyclophosphamide, Fludarabine, Axicabtagene Ciloleucel

Eligibility Information

Inclusion Criteria

Up to 5 prior regimens for MCL. Prior therapy must have included:
Anthracycline or bendamustine-containing chemotherapy and
Anti-CD20 monoclonal antibody therapy and
Ibrutinib or acalabrutinib
At least 1 measurable lesion
Platelet count ≥ 75,000/uL
Creatinine clearance (as estimated by Cockcroft Gault) > or = to 60 mL/min
Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings
Baseline oxygen saturation >92% on room air.

Exclusion Criteria

Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per standard serological and genetic testing
History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

Locations (32)

Banner MD Anderson

Gilbert, Arizona, United States, 85234

City of Hope

Duarte, California, United States, 91010

University California Los Angeles (UCLA)

Santa Monica, California, United States, 90404

Stanford University

Stanford, California, United States, 94305

Sarah Cannon

Denver, Colorado, United States, 80218

University of Miami

Miami, Florida, United States, 33136

H Lee Moffitt Cancer Center

Tampa, Florida, United States, 33612

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States, 30322

University of Chicago

Chicago, Illinois, United States, 60637

Loyola University Chicago

Maywood, Illinois, United States, 60153

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

University of Rochester Medical Center

Rochester, New York, United States, 14642

Duke University Medical Center

Durham, North Carolina, United States, 27710

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Ohio State University

Columbus, Ohio, United States, 43210

Robert W. Franz Cancer Research Center

Portland, Oregon, United States, 97213

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States, 75246

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Swedish Cancer Institute

Seattle, Washington, United States, 98104

Centre Hospitalier Universitaire (CHU)

Bordeaux, France

Hospital Saint Louis

Paris, France, 75010

Hopital Haut-Leveque

Pessac, France, 44035

Universitätsklinik Dresden

Dresden, Germany, 01307

Universitaetsklinikum Wuerzburg

Wuerzburg, Germany, 97080

Academisch Medisch Centrum

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) (ZUMA-2)

OVERVIEW

PROTOCOL SUMMARY